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Search Results for Clinical Research Associate
Job Title. | Location | Salary | Actions |
Associate Director Clinical DevelopmentAssociate Director Clinical Development Our client, a global pharma company, are continuing to add talented clinical professionals to their Clinical Development team, and are currently recruiting for an Associate Director to join their team on a permanent basis. You will have experience working in Clinical Trials/Clinical Research/Clinical Operations/Clinical Development and be an experienced people manager/team lead. This role is hybrid working, however, if you are living outside of the Republic of Ireland, relocation to Ireland is essential. Responsibilities: %...Location: Cork, |
Cork | Not Disclosed |
Clinical Research Associate Career Profile
Clinical Research Associate
The Clinical Research Associate is tasked with monitoring clinical trials sites in order to ensure that studies are carried in accordance with the study protocol, the company standard operating procedures (SOP), applicable regulations and the principles of ICH - GCP (International Conference on Harmonisation - Good Clinical Practice).
Key Responsibilities
- Identification of key investigators
- Assistance in the preparation of regulatory submissions
- Design patient information sheets and consent forms
- Coordinate document translation and verification
- Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements
- Pre-study and initiation visits
- Conduct regular monitoring visits in accordance with the trial site monitoring SOP
- Maintain all files and documentation pertaining to studies
- Motivate investigators in order to achieve recruitment targets
- Complete accurate study status reports.
- Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs
- Keep the project manager regularly informed
- Process case record forms to the required quality standards and timelines
- Ensure the satisfactory close-out of investigator sites
- Ensure correct archiving of files on completion of a study
- Co-operate with QA personnel in the conduct of QA audits
- Participate in feasibility studies for new proposals
- Maintain patient confidentiality
Qualifications / Experience Required
- Degree in Life Sciences or Equivalent
- Ability and willingness to travel at least 50% of the time, both international and local
- Ability to review and evaluate clinical data
- Computer literacy desirable
- Foreign language skills desirable
- Current full driving license essential
- Good oral and written communication skills
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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